Tailored, wEb-based, Psychosocial and Physical Activity Self-Management PrOgramme

NCT04304196 | Completed

• 1 other identifier: MP-CUSM-15-179
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Caregivers of men with prostate cancer report high physical and emotional distress, and there is an urgent need to develop cost-effective programmes to prepare them for their roles. An online tool has been developed recently, aiming to offer a convenient, efficient, and potentially effective solution. However, pilot testing is required to evaluate this dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgramme (called TEMPO) for caregivers of prostate cancer survivors. This study will assess TEMPO's acceptability, feasibility, cost, and potential efficacy, in addition to documenting the benefits (costs and outcomes) gained from involving both the caregiver and the patient in the intervention. A total of 80 patient-caregiver dyads will be recruited and randomized to a) TEMPO, or b) usual care. Acceptability, feasibility, and cost indicators will also be collected. Quality of life, anxiety, self-management skills, physical activity, self-efficacy, appraisal, and depression will also be assessed at baseline and 3 months post-baseline. In addition, intervention dyads will be invited to participate in an exit interview. This pilot study aims to assess the feasibility of the project, to inform the development and planning of a larger trial.

Conditions

Cancer of Prostate; Anxiety

Keywords

Caregiver; Self-directed online interventions; Coping; Self-management; Cancer; Physical activity

Outcome Measures

Primary Outcomes (5)

• Consent and follow-up rates

  Number of consenting dyads per week over the recruitment period

  From recruitment launch to completion of follow-up (12 months)

• Data completion rate

  Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.

  At T2: 13 weeks

• Fidelity of intervention completion

  Logs will be used to evaluate completion of intervention, as per protocol (e.g., number of log-ins, time spent, modules completed).

  At T2: 13 weeks

• Rate of tool use

  A 26-item questionnaire was developed by the team to evaluate the tool use. Each statement is scored using a 7-point likert scale, ranging from "completely disagree" to "completely agree". The total score is calculated by combining each individual item score. The total score ranges from 0 to 156. Higher score means better outcomes.

  At T2: 13 weeks

• Service Usability Scale

  The Service Usability Scale will be used. The score (1-5 Likert Scale, ranging from "strongly disagree" to "strongly agree") of the 10 statements will be combined into a final note (between 10 and 50). Higher score means better outcomes.

  At T2: 13 weeks

Study Arms (2)

TEMPO

EXPERIMENTAL

These patients and caregivers will be able to access the TEMPO modules and will receive technical support to use it effectively. Patients will receive usual care throughout the study.

Other: TEMPO

Control

ACTIVE COMPARATOR

Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team, but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Participants will be given access to the TEMPO website after having completed their final questionnaire, as thanks for participating.

Other: Usual care

Interventions

TEMPO OTHER

TEMPO is designed as a 7- to 10-week, web-based intervention containing 5 modules to pace patient-caregiver dyads' learning, avoid information overload, and allow sufficient practice time in-between modules . Each module is organized along six key components: needs assessment, tailored information and skills training, goal setting and action planning, motivational and social support, monitoring, automated feedback, and addressing time demands. Overall, modules aim to a) increase dyads' confidence in using strategies to address key psychosocial issues in the acute survivorship phase (e.g., dealing with stress and worry, communicating with partner and family, uncertainty management) and b) assist dyads in developing the self-regulatory skills necessary to meet the physical activity guidelines. Each module specifies a series of online (i.e. didactic material and interactive worksheets) and offline activities (i.e. practicing the proposed skills).

Also known as: Tailored, wEb-based, Psychosocial and Physical Activity Self-Management PrOgramme

TEMPO

Usual care OTHER

Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team, but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Participants will be given access to the TEMPO website after having completed their final questionnaire, as thanks for participating.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed prostate cancer diagnosis (localized or advanced) within the past two years,
• identified a primary caregiver willing to participate in the study,
• is undergoing or has undergone active treatment (i.e., surgery, chemotherapy, radiotherapy, and/or hormonotherapy),
• has access to the internet,
• understands English

You may not qualify if:

• medical contraindications to participate in moderate physical activity
• identified as a primary caregiver by an eligible patient willing to participate in the study
• understands English
• diagnosed with cancer in the previous year
• currently receiving treatment for cancer will be excluded
• medical contraindications to participate in moderate physical activity

Sponsors & Collaborators

• St. Mary's Research Center, Canada: lead

Study Sites (1)

St Mary's Hospital Centre

Montreal, Quebec, H3T1M5, Canada

Location

Related Publications (1)

• Lambert SD, Duncan LR, Ellis J, Robinson JW, Sears C, Culos-Reed N, Matthew A, De Raad M, Schaffler JL, Mina DS, Saha-Chaudhuri P, McTaggart-Cowan H, Peacock S. A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers. Pilot Feasibility Stud. 2021 Mar 20;7(1):78. doi: 10.1186/s40814-021-00791-6.

  PMID: 33743804 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders; Neoplasms; Motor Activity

Interventions

TEMPO

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders; Behavior

Study Officials

• Sylvie Lambert, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist

Model Details: This pilot study is a multicenter, stratified, parallel, two-group randomized controlled trial.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: June 1, 2020
• Primary Completion: May 29, 2021
• Study Completion: May 29, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)